Senior Qa Lead
CurrentThe organization leverages its expertise in software development and data analytics to support drug trials, providing innovative solutions that help pharmaceutical companies to streamline their processes, reduce costs, and accelerate time-to-market for new treatments.Ensuring that testing practices are in compliance with the regulatory statutes including 21 CFR Part11 and 50, ICH E6 Guideline for Good Clinical Practices, as well as company SOPS. Developing and validating functional and regression test scripts, OQ documents, and other qualitysystem related documents in line with GCP and user acceptance testing using Zephyr TestManagement tool in Jira for various Clinical Trial products such as EDC, IWR, ePRO, eTMF, SDMS,etc., Interviewed, trained, mentored, and provided leadership to new team members, ensuring asmooth transition into the project. Ensuring that the software operates properly, is free of defects, and meets business needs, loggingand tracking defects in Jira and retesting. Complies with and enforces the standards in the software life cycle SOPs and follows establishedstrategies, plans & procedure. Hands on experience in various software development methodologies like Agile and Waterfallmodel. Working in project Estimation and task allocation in Agile environment using Jira tool. Been part of creating QA Test Process, QA Workflow Diagrams, analysis and design, Test AnalysisReport, Defect Analysis and Prioritization. Data review and Clinical Data Validation to ensure the quality and integrity of the data in accordance with protocol specifications. Involved in executing the SQL Queries for Data Validation, Record Counting and Non-DuplicationTesting.